法规知识库 · EMA 集中审评
Pemetrexed Krka
pemetrexed disodium · EMEA/H/C/003958 · 已撤市
获批上市许可
2018-05-22
欧委会决定日
2023-02-15
持有人 / 申请人
KRKA tovarna zdravil d.d. Novo mesto
终止日期字段
无
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:L01BA04
治疗领域:Carcinoma, Non-Small-Cell Lung;Mesothelioma
药理分类:Antineoplastic agents
修订号:6 · 最新影响 PI 的程序:R/0009
适应症(原文):Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2023-02-15 · 欧委会决定
2018-05-22 · 获批上市许可
2018-03-22 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url;本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Pemetrexed Krka : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-07-30
- 打开官方文件 ↗
Pemetrexed Krka : EPAR - Risk-management-plan summary
rmp-summary · 2024-07-30
- 打开官方文件 ↗
Pemetrexed Krka : EPAR - Medicine overview
overview · 2024-07-30 · EMA/303183/2018
- 打开官方文件 ↗
Pemetrexed Krka : EPAR - Public assessment report
assessment-report · 2024-07-30 · EMA/CHMP/225126/2018
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。